Bamlanivimab prevents COVID-19 morbidity and mortality in nursing-home setting

ABSTRACT

Background: The COVID-19 pandemic has disproportionately affected residents of skilled nursing and assisted living facilities. Interventions are urgently needed to protect this vulnerable population. Bamlanivimab is a potent neutralizing monoclonal antibody that binds the receptor-binding domain of the spike protein of SARS-CoV-2. This study evaluates the safety and efficacy of bamlanivimab in preventing COVID-19. Methods: BLAZE-2 is a Phase 3, randomized, double-blind, placebo-controlled, single-dose study that enrolled residents and staff at skilled nursing and assisted living facilities reporting at least one confirmed SARS-CoV-2 case. Eligible participants received bamlanivimab (4200 mg) or placebo intravenously. Nasal swabs were collected at baseline and weekly through day 57 to determine SARS-CoV-2 infection status via reverse transcriptase polymerase chain reaction (RT-PCR). COVID-19-releated symptoms and signs were recorded daily. The primary analysis prevention population included participants negative at baseline for SARS-CoV-2 by RT-PCR and serology. The primary endpoint was incidence of mild or worse COVID-19 by day 57. Results: Of the 1175 participants dosed, 966 (82.2%) comprised the prevention population. The prevention population included 299 residents for whom the median age was 76 years (range 31-104), 234 (78.3%) were aged ≥65, and 178 (59.5%) were female. All were considered at high risk for development of severe COVID-19. The proportion of residents in the prevention population with mild or worse COVID-19 by day 57 was significantly lower in the bamlanivimab group compared with the placebo group (odds ratio [OR], 0.20;95% confidence interval [CI], 0.08 to 0.49;p<0.001)(Figure). For this same group, bamlanivimab was associated with significant reductions in the incidence of moderate or worse COVID-19 by day 57 (OR, 0.20;95% CI, 0.08 to 0.49;p<0.001) and incident SARS-CoV-2 infection by day 29 (OR, 0.23;CI, 0.11 to 0.48;p<0.001) compared with placebo. Of the 16 deaths reported during the study, all 5 that were attributed to COVID-19 were in the placebo group. The incidence of both adverse events and serious adverse events were balanced between the bamlanivimab and placebo group. Conclusion: Bamlanivimab was highly effective in reducing the incidence of symptomatic COVID-19 and SARS-CoV-2 infection and was well tolerated. These findings demonstrate the potential beneficial impact of bamlanivimab use on COVID-19 morbidity and mortality among skilled nursing facility residents.